Multiple SclerosisNCT04157283
Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
An observational study of Multiple Sclerosis and Sexual Dysfunction, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
This work aims to: 1. Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on 1. Specific neurologic deficit. 2. Depressive symptoms. 3. Comorbid factors. 4. Fatigue symptoms. 2. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Multiple Sclerosis, Sexual Dysfunction
- What is being tested?
- MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Nov 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases
Who may be able to join
- 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals
Who cannot join
- The exclusion criteria:
- Active relapse or relapse during 30 day prior to survey due to significant changes in all life activities during this period including sexuality.
- EDSS score equal or higher than 6.5.
- Current pregnancy in female patients.
- Form of the disease other than RRMS.
- Patients with any sort of cognitive impairment preventing them from understanding Questionnaire.
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- Poorly controlled concomitant diseases were excluded.
- Patients with past history of any sexual problems prior to the first MS attack.
- UN married Patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
Esmael M Ahmed, MD, 00201000382898, deltaneuro@yahoo.com
Esmael M Ahmed, MD
About this study
This work aims to:
- Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on
- Specific neurologic deficit.
- Depressive symptoms.
- Comorbid factors.
- Fatigue symptoms.
- To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
- To search for possible gender difference.
Read the detailed description
The present study is a cross sectional study on 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals, Egypt.
All patients were subjected to the following:
- Clinical Evaluation:
- Thorough neurological examination.
- Cognitive functions by Minimental State Examination (MMSE).
- Expanded Disability Severity Scale (EDSS).
- Neurophysiological Evaluation:
- Visual Evoked Potential (VEP).
- Imaging Evaluation:
- Conventional MRI.
- Cerebrospinal Fluid (CSF):
- Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
- Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
- Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).
- Conditions
- Multiple Sclerosis, Sexual Dysfunction
- Being tested
- MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)
- Medical subject headings
- Multiple Sclerosis, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)Diagnostic test
- Neurophysiological Evaluation: Visual Evoked Potential (VEP).
- Imaging Evaluation: Conventional MRI.
- Cerebrospinal Fluid (CSF):
- Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
- Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
- Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 60 male patients Receives: Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54) | |
| Group 2 | 60 female patients Receives: Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sexual Quality of Life-Male (SQOL-M)
Assesses the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best)-completely Agree = 1 to Completely Disagree = 6. The total score can range from 11 to 66 points.
Measured: 24-48 hours
The Sexual Quality of Life-Female (SQOL-F)
Assesses the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
Measured: 24-48 hours
The international index of erectile function (IIEF)
It's formed of 15 questions about main domains of male sexual function and each one had a score of 0-5 but used in Arabic translation.
Measured: 24-48 hours
Secondary outcomes (2)
Beck's Depression Inventory
The highest possible total for the whole test would be sixty-three. The lowest possible score for each question is zero, the lowest possible score for the test would be zero. This would mean you circles zero on each question. You can evaluate your depression according to the score below:
1-10 score considered normal. 11-16 score considered Mild depression. 17-20 score considered borderline clinical depression. 21-30 score considered moderate depression. 31-40score considered severe depression. Over 40 score considered extreme depression
Measured: 24-48 hours
Fatigue symptoms
Modified Fatigue Impact Scale (MFIS):
Items on the MFIS can be aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales but used in Arabic translation.
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start5 Nov 2019
- Primary completion5 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157283
- Sponsor's protocol ID
- Mansoura University Hospital 3
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
PubMed 189709772) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.
Fangerau T, Schimrigk S, Haupts M, Kaeder M, Ahle G, Brune N, Klinkenberg K, Kotterba S, Mohring M, Sindern E; Multiple Sclerosis Study Group. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Scand. 2004 Jun;109(6):385-9. doi: 10.1111/j.1600-0404.2004.00246.x.
PubMed 15147460Fraser C, Mahoney J, McGurl J. Correlates of sexual dysfunction in men and women with multiple sclerosis. J Neurosci Nurs. 2008 Oct;40(5):312-7. doi: 10.1097/01376517-200810000-00010.
PubMed 18856253Freedman MS, Thompson EJ, Deisenhammer F, Giovannoni G, Grimsley G, Keir G, Ohman S, Racke MK, Sharief M, Sindic CJ, Sellebjerg F, Tourtellotte WW. Recommended standard of cerebrospinal fluid analysis in the diagnosis of multiple sclerosis: a consensus statement. Arch Neurol. 2005 Jun;62(6):865-70. doi: 10.1001/archneur.62.6.865.
PubMed 15956157Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
PubMed 16168933Lew-Starowicz M, Gianotten WL. Sexual dysfunction in patients with multiple sclerosis. Handb Clin Neurol. 2015;130:357-70. doi: 10.1016/B978-0-444-63247-0.00020-1.
PubMed 26003254Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. doi: 10.1016/S1474-4422(04)00933-0.
PubMed 15556803Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
PubMed 21387374Zivadinov R, Zorzon M, Bosco A, Bragadin LM, Moretti R, Bonfigli L, Iona LG, Cazzato G. Sexual dysfunction in multiple sclerosis: II. Correlation analysis. Mult Scler. 1999 Dec;5(6):428-31. doi: 10.1177/135245859900500i610.
PubMed 10618700
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities
- ClinicalTrials.gov ID
- NCT04157283
- Acronym / sponsor ID
- Mansoura University Hospital 3
- Conditions
- Multiple Sclerosis, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 5 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work aims to:
- Investigate and correlate Sexual Dysfunction in relapsing-remitting Multiple Sclerosis patients with specific focus on
- Specific neurologic deficit.
- Depressive symptoms.
- Comorbid factors.
- Fatigue symptoms.
- To investigate the impact of Sexual dysfunction on Sexual Quality of Life (SQoL).
- To search for possible gender difference.
Detailed description
The present study is a cross sectional study on 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals, Egypt.
All patients were subjected to the following:
- Clinical Evaluation:
- Thorough neurological examination.
- Cognitive functions by Minimental State Examination (MMSE).
- Expanded Disability Severity Scale (EDSS).
- Neurophysiological Evaluation:
- Visual Evoked Potential (VEP).
- Imaging Evaluation:
- Conventional MRI.
- Cerebrospinal Fluid (CSF):
- Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
- Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
- Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)60 male patients |
| Group 2 | – | Diagnostic Test: MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)60 female patients |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases
Key inclusion criteria (1 listed)
- 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals
Key exclusion criteria (9 listed)
- Active relapse or relapse during 30 day prior to survey due to significant changes in all life activities during this period including sexuality.
- EDSS score equal or higher than 6.5.
- Current pregnancy in female patients.
- Form of the disease other than RRMS.
- Patients with any sort of cognitive impairment preventing them from understanding Questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)1. Neurophysiological Evaluation: Visual Evoked Potential (VEP). 2. Imaging Evaluation: Conventional MRI. 3. Cerebrospinal Fluid (CSF): 4. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994). 5. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression. 6. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54). | Diagnostic test | Group 1, Group 2 |
Primary outcome
The Sexual Quality of Life-Male (SQOL-M)
Time frame: 24-48 hours
Assesses the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best)-completely Agree = 1 to Completely Disagree = 6. The total score can range from 11 to 66 points.
The Sexual Quality of Life-Female (SQOL-F)
Time frame: 24-48 hours
Assesses the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.
The international index of erectile function (IIEF)
Time frame: 24-48 hours
It's formed of 15 questions about main domains of male sexual function and each one had a score of 0-5 but used in Arabic translation.
2 secondary outcomes
Beck's Depression Inventory
Time frame: 24-48 hours
Fatigue symptoms
Time frame: 24-48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Results publication: PubMed 18970977Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
- Results publication2) Chan,K.,& Tsang, L. (2011). Promote healthy eating among adolescents:A Hong Kong study . Journal of Consumer Marketing, 28(5), 354-362.
- Results publication: PubMed 15147460Fangerau T, Schimrigk S, Haupts M, Kaeder M, Ahle G, Brune N, Klinkenberg K, Kotterba S, Mohring M, Sindern E; Multiple Sclerosis Study Group. Diagnosis of multiple sclerosis: comparison of the Poser criteria and the new McDonald criteria. Acta Neurol Scand. 2004 Jun;109(6):385-9. doi: 10.1111/j.1600-0404.2004.00246.x.
- Results publication: PubMed 18856253Fraser C, Mahoney J, McGurl J. Correlates of sexual dysfunction in men and women with multiple sclerosis. J Neurosci Nurs. 2008 Oct;40(5):312-7. doi: 10.1097/01376517-200810000-00010.
- Results publication: PubMed 15956157Freedman MS, Thompson EJ, Deisenhammer F, Giovannoni G, Grimsley G, Keir G, Ohman S, Racke MK, Sharief M, Sindic CJ, Sellebjerg F, Tourtellotte WW. Recommended standard of cerebrospinal fluid analysis in the diagnosis of multiple sclerosis: a consensus statement. Arch Neurol. 2005 Jun;62(6):865-70. doi: 10.1001/archneur.62.6.865.
- Results publication: PubMed 16168933Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
- Results publication: PubMed 26003254Lew-Starowicz M, Gianotten WL. Sexual dysfunction in patients with multiple sclerosis. Handb Clin Neurol. 2015;130:357-70. doi: 10.1016/B978-0-444-63247-0.00020-1.
- Results publication: PubMed 15556803Marrie RA. Environmental risk factors in multiple sclerosis aetiology. Lancet Neurol. 2004 Dec;3(12):709-18. doi: 10.1016/S1474-4422(04)00933-0.
- Results publication: PubMed 21387374Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
- Results publication: PubMed 10618700Zivadinov R, Zorzon M, Bosco A, Bragadin LM, Moretti R, Bonfigli L, Iona LG, Cazzato G. Sexual dysfunction in multiple sclerosis: II. Correlation analysis. Mult Scler. 1999 Dec;5(6):428-31. doi: 10.1177/135245859900500i610.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Sexual Dysfunction, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esmael M Ahmed, MD (00201000372787, deltaneuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sexual Quality of Life-Male (SQOL-M) (time frame: 24-48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157283, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.